Cigarette makers sue FDA over new labeling rules

By Jonathan Stempel

NEW YORK | Wed Aug 17, 2011 11:09am EDT

(Reuters) - Four big cigarette makers sued the Food and Drug Administration, seeking to void as unconstitutional new graphic labels and advertising that warn consumers about the risks of smoking and induce them to quit.

The lawsuit by Reynolds American Inc's R.J. Reynolds unit, Lorillard Inc, Liggett Group LLC and Commonwealth Brands Inc, owned by Britain's Imperial Tobacco Group Plc, said the warnings required no later than September 22, 2012 would force cigarette makers to "engage in anti-smoking advocacy" on the government's behalf.

They said this violates their free speech rights under the First Amendment, according to a complaint filed Tuesday with the U.S. District Court in Washington, D.C.

"The notion that the government can require those who manufacture a lawful product to emblazon half of its package with pictures and words admittedly drafted to persuade the public not to purchase that product cannot withstand constitutional scrutiny," said Floyd Abrams, a prominent First Amendment specialist representing the cigarette makers, in a statement.

An FDA spokeswoman declined to comment, citing an agency policy not to discuss pending litigation.

The 2009 Family Smoking Prevention and Tobacco Control Act requires color warnings covering the top half of the front and back panels of cigarette packages, and the top 20 percent of printed advertising.

Dead bodies, diseased lungs and rotting teeth are among the images expected to appear, in the first change to U.S. cigarette warnings in 25 years.

Reynolds' brands include Camel, Winston and Kool; Lorillard brands include Newport and True; Commonwealth brands include Davidoff, and Liggett brands include Eve.

KNOWING THE RISKS

The cigarette companies are the largest in the United States other than Altria Group Inc, whose brands include Marlboro and which is not part of the case. Altria had previously supported the 2009 law.

"Certain provisions of the final rule raise constitutional concerns," Altria spokesman Bill Phelps said. "We continue to work constructively with the FDA, and reserve our rights and options to protect the company."

A smaller cigarette maker, Santa Fe Natural Tobacco Co, is also a plaintiff in the lawsuit, which also seeks to delay enforcement of other parts of the tobacco law.

Kathleen Sebelius, Secretary of the Department of Health & Human Services, in June said the new warnings would ensure that "every person who picks up a pack of cigarettes is going to know exactly what risks they are taking."

She said the goal was to stop children from starting to smoke, and to give adult smokers a new incentive to quit.

"MINI-BILLBOARD"

But in their complaint, the cigarette companies said the labels illegally force them to make consumers "depressed, discouraged and afraid" to buy cigarettes, and turn each package into a "mini-billboard" for the government.

According to the Centers for Disease Control and Prevention, about 46 million U.S. adults, or 20.6 percent, smoke cigarettes, but there has been little change in the percentage since 2004.

More than 221,000 Americans are expected to be diagnosed with lung cancer in 2011, according to the American Cancer Society. Tobacco is expected to kill nearly 6 million people worldwide in 2011, including 600,000 nonsmokers, the World Health Organization said in May.

The case is R.J. Reynolds Tobacco Co et al v. FDA, U.S. District Court, District of Columbia, No. 11-01482.

(Reporting by Jonathan Stempel; Additional reporting by Anna Yukhananov in Washington, D.C.; editing by Bernard Orr, Carol Bishopric, Phil Berlowitz)